Astek

Kavo KA149 Pro-Tip Converter Kit incl. 1500 Tips

Registry build 21.09.26
56manufacturers in China registered for this device type
31catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (10), Shanghai (9). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ECB
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15
Yongqing Huaguan Dental Instruments Factory Langfang Hebei Contract manufacturer 9
Tianjin Jieyaxin Medical Plastic Equipment Co., Ltd. Tianjin Tianjin Contract manufacturer 6
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82

Showing 12 of 56. All 56 manufacturers in China registered for Unit, Syringe, Air And/Or Water

Record

Regulatory record for Astek
Listed by Young Innovations Inc., United States
FDA product code ECB
Device type Unit, Syringe, Air And/Or Water
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-12-01
Record revised 2023-05-08 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Packaging Package, case, package of 250, case of 6, case of 20, package of 25
Distribution end date 2023-12-12

Catalogue Numbers

Catalogue numbers for Astek
Catalogue number Size Status
116237ASTEK In distribution
116410 In distribution
116342ASTEK In distribution
116315ASTEK In distribution
116410SAMPLE In distribution
116430 In distribution
116346CEFLA In distribution
116208ASTEK In distribution
116346ASTEK In distribution
116342CEFLA In distribution
116200ASTEK In distribution
116490 In distribution
116239 In distribution
116235ASTEK In distribution
116238ASTEK In distribution
116343KIT In distribution
116235CEFLA In distribution
116244ASTEK In distribution
116346CEFLA Withdrawn
116342ASTEK Withdrawn
116344ASTEK Withdrawn
116238ASTEK Withdrawn
116201ASTEK Withdrawn
116226ASTEK Withdrawn
116208ASTEK Withdrawn
116218ASTEK Withdrawn
116216ASTEK Withdrawn
116239ASTEK Withdrawn
116411 Withdrawn
116345ASTEK Withdrawn
116200ASTEK Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DCI Parts DCI International, LLC 80
DCI DCI International, LLC 29
Crystal Tip Young Innovations Inc. 26
Natures Tip Young Innovations Inc. 22
Sani-Tip® Dentsply Professional 19
A-dec A-dec, Inc. 15
Essentials by 3D Dental 3D Dental Designs AND Development, LLC 14
Henry Schein Henry Schein, Inc. 12
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 12
Darby Dental Supply, LLC Darby Dental Supply, LLC 11
Starz Tipz Young Innovations Inc. 11
JMU JMU Dental, Inc 10

Showing 12 of 77. All products under Unit, Syringe, Air And/Or Water

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer